To settle a lawsuit, the FDA has agreed to remove controversial website and social media instruction waving patients off of using ivermectin for COVID-19.
The lawsuit was filed by physicians, including Dr. Paul Marik, chief scientific officer of the Front Line Critical Covid Care (FLCCC) Alliance, who argued that the FDA overstepped its bounds and distributed false or misleading information about ivermectin.
In a series of now-infamous tweets, FDA implied ivermectin was dangerous, and that it was intended only for horses and other animals.
Last September, a U.S. Court of Appeals for the Fifth Circuit criticized the FDA, noting that FDA failed to acknowledge that a safe and effective human form of the medicine has been in use for decades. The judges added, “FDA is not a physician. It has authority to inform, announce, and apprise—but not to endorse, denounce, or advise…FDA can inform, but it has identified no authority allowing it to recommend consumers ‘stop’ taking medicine” and “Even tweet-sized doses of personalized medical advice are beyond FDA’s statutory authority.”
We are extremely pleased with the outcome of the settlement as it is a victory for every doctor and patient in the United States. The FDA interfered in the practice of medicine with their irresponsible language and posts about ivermectin. We will never know how many lives were affected because patients were denied access to a lifesaving treatment because their doctor was ‘just following the FDA.’
Paul E. Marik, M.D., FCCM, FCCP, a plaintiff in the case, chief scientific officer of the FLCCC Alliance (FLCCC) and former Chief, Pulmonary and Critical Care Medicine at Eastern Virginia Medical School
The release from FLCCC is below.
FOR IMMEDIATE RELEASE
March 22, 2024
CONTACT:
FLCCC Alliance Statement on the Settlement Reached in Case Against DHHS for Telling the Public to “Stop it” Regarding Taking Ivermectin to Prevent and Treat COVID-19
WASHINGTON, D.C. – A settlement has been reached between the Food and Drug Administration (FDA) and the plaintiffs in a groundbreaking case filed in federal court to decide if the FDA violated its authority as a federal health agency in telling the public to stop taking ivermectin, a safe, well-studied, and proven drug for the prevention and treatment of COVID-19.
In the settlement, the FDA agreed to remove website and social media posts that make statements about using ivermectin for COVID-19.
“We are extremely pleased with the outcome of the settlement as it is a victory for every doctor and patient in the United States,” said Paul E. Marik, M.D., FCCM, FCCP, a plaintiff in the case, chief scientific officer of the FLCCC Alliance (FLCCC) and former Chief, Pulmonary and Critical Care Medicine at Eastern Virginia Medical School. “The FDA interfered in the practice of medicine with their irresponsible language and posts about ivermectin. We will never know how many lives were affected because patients were denied access to a lifesaving treatment because their doctor was ‘just following the FDA.’”
“I couldn’t be prouder of Paul and our colleagues for taking a stand for all of us against a government health agency that overstepped its authority,” said Pierre Kory, M.D., M.P.A., president and chief medical officer of the FLCCC. “The FDA knew exactly what it was doing when it tweeted that ivermectin was for horses and that people should ‘stop it.’ I hope this case will serve as precedent the next time a federal health agency steps out of its authority and tries to practice medicine.”
The lawsuit, Apter et al. v. Dep’t. of Health and Human Services et al., was brought by Robert Apter, MD, Mary Talley Bowden, MD, and Paul E. Marik, MD, and first filed in the U.S. District Court on June 2, 2022. It stated that theFDA acted outside of its authority and illegally interfered with the doctors’ ability to practice medicine with an aggressive effort to stop the use of ivermectin to prevent and treat COVID-19. The case was later dismissed by the court, citing that the FDA had “sovereign immunity,” giving the agency absolute protection from any wrongdoing or harm in directing the public, including health professionals and patients, not to use ivermectin, a drug that has received full FDA approval for human use. In September of last year, the U.S. Court of Appeals for the Fifth Circuit reversed the lower court’s dismissal of the lawsuit with a ruling that said the “FDA is not a physician. It has authority to inform, announce, and apprise—but not to endorse, denounce, or advise.” The ruling goes on to say that the “FDA can inform, but it has identified no authority allowing it to recommend consumers ‘stop’ taking medicine.” And finally, “Even tweet-sized doses of personalized medical advice are beyond FDA’s statutory authority.”
“The legal team’s work at Boyden Gray PLLC was exceptional,” Marik added. “My colleagues and I could not have asked for a better partner to represent us on this case. We are very grateful for their hard work.”
The settlement can be found here: https://www.documentcloud.org/documents/24495557-fda-stipulation-of-dismissal
The FLCCC filed its amicus brief supporting the lawsuit in February of 2023. A copy of the brief can be found here: https://covid19criticalcare.com/wp-content/uploads/2023/02/FLCCC-Apter-v-HHS-Amicus-2-13-23-FINAL.pdf
About the FLCCC Alliance
The FLCCC Alliance was organized in March 2020 by a group of highly published, world-renowned critical care physicians and scholars with the academic support of allied physicians worldwide. Known for its lifesaving protocols for preventing and treating COVID-19 in all stages of illness, including “Long COVID” and Post Vaccine Syndrome, the FLCCC has since developed treatment guides for several conditions and illnesses, including sepsis, metabolic disease, cancer, and depression. For more information: www.FLCCC.net
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Good! Now make CDC change their recently tortured new definition for “vaccine” which they also twisted beyond all recognition to cover what Big Pharm claimed their experimental clot shot would do.
Anyone using the CDC Travelers website page for years, saw hydroxycholoroquine and other malaria preventives recommended for travellers as appropriate drugs with a long term safety profiles.
Until Democrats and the deep state politicized “covid” into the Election Year 2020 Zombie Apocalypse used to take Trump down. We simply cannot keep funding any of these government agencies with our tax own dollars. They betray us at every level.
It’s amazing how fast the FDA swerved out of its lane, and how long it took — YEARS — to get it back into its lane.
This is NOT a hopeful indication. Nor is the absence of civil and CRIMINAL penalties for what the FDA did in MALICIOUSLY badmouthing Ivermectin with apparent INTENT to expontentially boost the COVID death toll — using pure political propaganda to turn what was essentially an outbreak of the flu into the equivalent of an outbreak of bubonic plague, setting western medicine back decades, if not centuries.
I don’t know if this will ever happen (in this CYA-CoverYourA–) Administration, but it would be fantastic if some investigative reporter found a that the Administration influenced the FDA to issue it’s edict of mis and mal-information.
The FDA wouldn’t have taken on itself to do what it did. The only one(s) who could have persuaded it-in a high handed and political manner is, I believe, the flacks-and possibly the highest ranking flacks-in the Biden Administration.
The mainstream media use to cover the corruption and deception of the Government (eg, remember the Pentagon Papers). Now the political persuasion of the Government leans towards MSM’s progressive ideas, so they sweep all the deceptions and corruptions of the Government under the rug.
Who will be the Vaccum Cleaner that cleans up this Government Administration?!
The FDA and Government is NOT your friend!
Regarding Covid…
I received my first enlightenment on this group back when the covid nonsense first exposed by an Amish group that was exposed to the killer disease. They simply drank the same water thus exposing themselves with the result that none of them fell sick.
Later I found out tha ivermectin cures the killer virus in less than five days just as advertised!
Again… The government IS NOT your friend!